Information on plant pesticide products autorization data requirements for co-formulants

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ÚKSÚP

For your information, from 1.6.2020 all applications for new authorisation of PPP, mutual recognition of PPP, renewal of PPP and composition change of PPP, concerning data requirements according to Article 33 (3a) and 42 (1c) of Regulation (EC) No 1107/2009 of the European Parliament and the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC and according to Part A of Annex, Section 1, Point 1.4.3. of Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market the full composition of co-formulants used in relevant PPP will be required.

According to the above-mentioned requirements co-formulants shall, where possible, be identified both by their chemical name as given in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council or, if not included in that Regulation, in accordance with both the International Union of Pure and Applied Chemistry (IUPAC) and Chemical Abstracts (CA) nomenclature. Their structural formula shall be provided. For each component of the co-formulants the relevant EC number and Chemical Abstracts Service (CAS) number, where they exist, shall be provided. For co-formulants which are mixtures, the composition shall be provided. Where the information provided does not fully identify the co-formulant, an appropriate specification shall be provided. The trade name, where available, shall also be provided. Safety data sheets pursuant to Article 31 of Regulation (EC) No 1907/2006 (*) shall be provided. They shall be up to date and in accordance with other Union legislation.

The applicant shall ensure the delivery of the required documentation even if it does not have access to it, composition should be delivered from co-formulant manufacturer to UKSUP.